Multi-criteria decision analysis (MCDA) models in health technology assessment of orphan drugs—a systematic literature review. Next steps in methodology …

A Baran-Kooiker, M Czech, C Kooiker - Frontiers in public health, 2018 - frontiersin.org
… To measure “Advancement of technology”, Kolasa et al. (34) made a distinction between
Advanced therapy medicinal products (ATMPs), complex drugs, small molecules (with at least …

[图书][B] Medical product regulatory affairs: pharmaceuticals, diagnostics, medical devices

JJ Tobin, G Walsh - 2023 - books.google.com
… Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November
2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and …

Re-engineering the innovator–clinic interface for adoption of advanced therapies

N Medcalf - Regenerative Medicine, 2021 - Taylor & Francis
… The arrival of advanced therapy medicinal products (ATMPs) and, in particular, those … in
these assessments are the Health Technology Assessment (HTA) bodies. HTA bodies assess

[PDF][PDF] Deliberative Appraisal Processes in Health Technology Assessment

M Richardson, N Mittmann… - … of Health Technologies, 2021 - canjhealthtechnol.ca
… considerations for the deliberative appraisal of pharmaceutical products with overlap on …
for example, the Medical Device and Health Technology Evaluation Committee at HAS includes …

Funding breakthrough therapies: a systematic review and recommendation

E Hanna, M Toumi, C Dussart, B Borissov, O Dabbous… - Health Policy, 2018 - Elsevier
… Among innovative therapies, there is a … Advanced Therapy Medicinal Products (ATMPs) in
Europe, that include somatic cell therapies, gene therapies and tissue-engineered products [2]…

Is regulatory innovation fit for purpose? A case study of adaptive regulation for advanced biotherapeutics

G De Grandis, I Brass, SS Farid - Regulation & Governance, 2023 - Wiley Online Library
… such as health technology assessment (HTA) bodies have to make critical reimbursement
decisions, balancing a product's … (EC) No 1394/2007 on advanced therapy medicinal products. …

Delivering advanced therapies: the big pharma approach

J Tarnowski, D Krishna, L Jespers, A Ketkar… - Gene Therapy, 2017 - nature.com
… of an autologous gene therapy medicine and illuminated where product, process and … drug
product can be administered in an ex vivo or in vivo setting. Ex vivo autologous gene therapy

[图书][B] Davidson's Principles and Practice of Medicine: Davidson's Principles and Practice of Medicine E-Book

SH Ralston, ID Penman, MWJ Strachan, R Hobson - 2018 - books.google.com
More than two million medical students, doctors and other health professionals around the
globe have owned a copy of Davidson’s Principles and Practice of Medicine since it was first …

[图书][B] Health, technology and society

A Webster, S Wyatt - 2020 - Springer
… ’ of advanced therapies: limited … a healthcare provider (eg a hospital) or at a ‘higher-level’
governance institution, such as a Health Technology Assessment (HTA) (if it is a therapeutic or …

[HTML][HTML] Scientific considerations for the regulatory evaluation of cell therapy products

J Petricciani, T Hayakawa, G Stacey, JH Trouvin… - Biologicals, 2017 - Elsevier
advanced therapy medicinal products … are usually included as an Advanced Therapy
Medicinal Product (ATMP) in … followup-risk management of advanced therapy medicinal products